Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers (NOVA)
The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jung-hee Ham Project Manager, Registered Nurse
- Telefonnummer: 82-2-3010-4728
- E-mail: cvcrc5@amc.seoul.kr
Studiesteder
-
-
-
Seoul, Sydkorea
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Jung-min Ahn, MD
- Telefonnummer: 82-2-3010-4728
- E-mail: cvcrc5@amc.seoul.kr
-
Ledende efterforsker:
- Jung-min Ahn, MD, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult men and women aged 19 years or older
- Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
- Patients who have voluntarily provided written informed consent to participate in the study
Exclusion Criteria:
-
Cardiogenic shock within 48 hours prior to the procedure
-
Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
-
Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
-
Women who are pregnant, breastfeeding, or of childbearing potential who meet any of the following:
- Have not confirmed a negative pregnancy test prior to enrollment
- Do not agree to use, or are unlikely to maintain, an acceptable method of contraception during the study period
-
Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
-
Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
-
Patients who are unwilling or unable to comply with the study protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sirolimus-Ascorbic Acid Eluting Stent
D+STORM NOVONIX stent |
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent |
|
Aktiv komparator: Everolimus-Eluting Stent
SYNERGY XD |
bioabsorbable polymer everolimus-eluting stent |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The event rate of Target Lesion Failure
Tidsramme: 1 year
|
Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization. |
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The event rate of Device success
Tidsramme: 1 year
|
Acute Success Endpoints_lesion level |
1 year
|
|
The event rate of Procedural success
Tidsramme: 1 year
|
Acute Success Endpoints_patient level |
1 year
|
|
The event rate of Death from any causes
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any stroke
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any myocardial infarction
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Any repeat revascularization
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE |
1 year
|
|
The event rate of Cardiovascular death
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel myocardial infarction
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of Target vessel revascularization
Tidsramme: 1 year
|
Major Composite Clinical Endpoints_Target Vessel Failure |
1 year
|
|
The event rate of All-cause death
Tidsramme: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Cardiac death
Tidsramme: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of Non-cardiac death
Tidsramme: 1 year
|
Individual Clinical Endpoints_Mortality |
1 year
|
|
The event rate of All myocardial infarction including Q wave and Non-Q wave
Tidsramme: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of Non-target vessel myocardial infarction
Tidsramme: 1 year
|
Individual Clinical Endpoints_Myocardial Infarction |
1 year
|
|
The event rate of All revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target lesion revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of All target vessel revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Non-target vessel revascularization
Tidsramme: 1 year
|
Individual Clinical Endpoints_Revascularization |
1 year
|
|
The event rate of Any stroke
Tidsramme: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Ischemic stroke
Tidsramme: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
|
The event rate of Hemorrhagic stroke
Tidsramme: 1 year
|
Individual Clinical Endpoints_Stroke |
1 year
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The event rate of Definite or probable stent thrombosis
Tidsramme: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Definite stent thrombosis
Tidsramme: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of Probable stent thrombosis
Tidsramme: 1 year
|
Safety Endpoints |
1 year
|
|
The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5
Tidsramme: 1 year
|
Safety Endpoints |
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AMCCV 2026-02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .